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Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19).
Lippi, Giuseppe; Simundic, Ana-Maria; Plebani, Mario.
  • Lippi G; Section of Clinical Biochemistry, Department of Neuroscience, Biomedicine and Movement, University of Verona, Piazzale LA Scuro, 37134 Verona, Italy.
  • Simundic AM; Department of Medical Laboratory Diagnostics, University Hospital Sveti Duh, Zagreb, Croatia.
  • Plebani M; Department of Laboratory Medicine, University Hospital of Padova, Padova, Italy.
Clin Chem Lab Med ; 58(7): 1070-1076, 2020 06 25.
Article in English | MEDLINE | ID: covidwho-8733
ABSTRACT
A novel zoonotic coronavirus outbreak is spreading all over the world. This pandemic disease has now been defined as novel coronavirus disease 2019 (COVID-19), and is sustained by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As the current gold standard for the etiological diagnosis of SARS-CoV-2 infection is (real time) reverse transcription polymerase chain reaction (rRT-PCR) on respiratory tract specimens, the diagnostic accuracy of this technique shall be considered a foremost prerequisite. Overall, potential RT-PCR vulnerabilities include general preanalytical issues such as identification problems, inadequate procedures for collection, handling, transport and storage of the swabs, collection of inappropriate or inadequate material (for quality or volume), presence of interfering substances, manual errors, as well as specific aspects such as sample contamination and testing patients receiving antiretroviral therapy. Some analytical problems may also contribute to jeopardize the diagnostic accuracy, including testing outside the diagnostic window, active viral recombination, use of inadequately validated assays, insufficient harmonization, instrument malfunctioning, along with other specific technical issues. Some practical indications can hence be identified for minimizing the risk of diagnostic errors, encompassing the improvement of diagnostic accuracy by combining clinical evidence with results of chest computed tomography (CT) and RT-PCR, interpretation of RT-PCR results according to epidemiologic, clinical and radiological factors, recollection and testing of upper (or lower) respiratory specimens in patients with negative RT-PCR test results and high suspicion or probability of infection, dissemination of clear instructions for specimen (especially swab) collection, management and storage, together with refinement of molecular target(s) and thorough compliance with analytical procedures, including quality assurance.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Medical Errors / Pandemics / Scientific Experimental Error Type of study: Diagnostic study / Etiology study / Prognostic study Limits: Humans Language: English Journal: Clin Chem Lab Med Journal subject: Chemistry, Clinical / Laboratory Techniques and procedures Year: 2020 Document Type: Article Affiliation country: Cclm-2020-0285

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Medical Errors / Pandemics / Scientific Experimental Error Type of study: Diagnostic study / Etiology study / Prognostic study Limits: Humans Language: English Journal: Clin Chem Lab Med Journal subject: Chemistry, Clinical / Laboratory Techniques and procedures Year: 2020 Document Type: Article Affiliation country: Cclm-2020-0285